B. Bhaskar Gollapudi
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View article: A critical evaluation of rodent carcinogenicity studies on butyl methacrylate demonstrates a lack of carcinogenic potential
A critical evaluation of rodent carcinogenicity studies on butyl methacrylate demonstrates a lack of carcinogenic potential Open
Assessments of a chemical agent's carcinogenicity based on rodent bioassays rely on their appropriate interpretation. This involves attention to study details, including reliable histopathologic diagnoses, and proper statistical analyses, …
View article: Investigation of mutagenicity of styrene in tumor target and non‐target tissues of transgenic Big Blue® mice
Investigation of mutagenicity of styrene in tumor target and non‐target tissues of transgenic Big Blue® mice Open
Styrene has been shown to induce lung tumors in mice, but not in rats. The current study investigated the potential role of genotoxicity as an initial key event in the mode of action for styrene‐induced lung tumors in mice. Transgenic male…
View article: <scp>Severity of effect considerations regarding the use of mutation as a toxicological endpoint for risk assessment: A report from the 8th International Workshop on Genotoxicity Testing</scp> (<scp>IWGT</scp>)
<span>Severity of effect considerations regarding the use of mutation as a toxicological endpoint for risk assessment: A report from the 8th International Workshop on Genotoxicity Testing</span> (<span>IWGT</span>) Open
Exposure levels without appreciable human health risk may be determined by dividing a point of departure on a dose–response curve (e.g., benchmark dose) by a composite adjustment factor (AF). An “effect severity” AF (ESAF) is employed in s…
View article: Investigations on the genotoxic potential of styrene in Fischer 344 rats using multiple endpoints
Investigations on the genotoxic potential of styrene in Fischer 344 rats using multiple endpoints Open
Genotoxicity of styrene monomer was evaluated in male Fischer 344 rats using the alkaline comet assay for DNA damage, micronucleus assay for cytogenetic damage and the Pig‐a assay for gene mutations. In a dose range finding (DRF) study, st…
View article: Interpretation of in vitro concentration‐response data for risk assessment and regulatory decision‐making: Report from the 2022 <scp>IWGT</scp> quantitative analysis expert working group meeting
Interpretation of in vitro concentration‐response data for risk assessment and regulatory decision‐making: Report from the 2022 <span>IWGT</span> quantitative analysis expert working group meeting Open
Quantitative risk assessments of chemicals are routinely performed using in vivo data from rodents; however, there is growing recognition that non‐animal approaches can be human‐relevant alternatives. There is an urgent need to build confi…
View article: Evaluation of the carcinogenicity of carbon tetrachloride
Evaluation of the carcinogenicity of carbon tetrachloride Open
Carbon tetrachloride (CCl4) has been extensively used and reported to produce toxicity, most notably involving the liver. Carbon tetrachloride metabolism involves CYP450-mediated bioactivation to trichloromethyl and trichloromethyl peroxy …
View article: Interpretation of In Vitro Concentration-Response Data for Risk Assessment and Regulatory Decision-making: Report from 2022 IWGT Quantitative Analysis Expert Working Group Meeting
Interpretation of In Vitro Concentration-Response Data for Risk Assessment and Regulatory Decision-making: Report from 2022 IWGT Quantitative Analysis Expert Working Group Meeting Open
Quantitative risk assessments of chemicals are routinely performed in rodents; however, there is growing recognition that non-animal approaches can be human-relevant alternatives. There is an urgent need to build confidence in non-animal a…
View article: Investigation of the potential mutagenicity of ethyl tertiary‐butyl ether in the tumor target tissue using transgenic Big Blue Fischer 344 rats following whole body inhalation exposure
Investigation of the potential mutagenicity of ethyl tertiary‐butyl ether in the tumor target tissue using transgenic Big Blue Fischer 344 rats following whole body inhalation exposure Open
Ethyl tertiary‐butyl ether (ETBE) is a fuel oxygenate used for the efficiency of motor vehicle fuels and their octane ratings. ETBE has been reported to induce liver adenomas in male rats in a 2‐year bioassay at the highest inhalation conc…
View article: In vitro and in vivo assessments of the genotoxic potential of 3‐chloroallyl alcohol
In vitro and in vivo assessments of the genotoxic potential of 3‐chloroallyl alcohol Open
3‐Chloroallyl alcohol (3‐CAA) can be found in the environment following the application of plant protection products. 3‐CAA is formed in groundwater following the injection of 1,3‐dichloropropene, a fumigant used to control nematodes. 3‐CA…
View article: Impact of sampling time on the detection of mutations in rapidly proliferating tissues using transgenic rodent gene mutation models: A review
Impact of sampling time on the detection of mutations in rapidly proliferating tissues using transgenic rodent gene mutation models: A review Open
The OECD Test Guideline 488 (TG 488) for the Transgenic Rodent Gene Mutation Assay has undergone several revisions to update the recommended design for studying mutations in somatic tissues and male germ cells. The recently revised TG reco…
View article: Methyl-tert-butyl ether (MTBE): integration of rat and mouse carcinogenicity data with mode of action and human and rodent bioassay dosimetry and toxicokinetics indicates MTBE is not a plausible human carcinogen
Methyl-tert-butyl ether (MTBE): integration of rat and mouse carcinogenicity data with mode of action and human and rodent bioassay dosimetry and toxicokinetics indicates MTBE is not a plausible human carcinogen Open
Methyl-tert-butyl ether (MTBE) is a fuel oxygenate used in non-United States geographies. Multiple health reviews conclude that MTBE is not a human-relevant carcinogen, and this review provides updated mode of action (MOA), exposure, dosim…
View article: Permitted daily exposure limits for noteworthy <i>N‐nitrosamines</i>
Permitted daily exposure limits for noteworthy <i>N‐nitrosamines</i> Open
A genotoxic carcinogen, N ‐nitrosodimethylamine (NDMA), was detected as a synthesis impurity in some valsartan drugs in 2018, and other N ‐nitrosamines, such as N ‐nitrosodiethylamine (NDEA), were later detected in other sartan products. N…
View article: Recommendations for conducting the rodent erythrocyte <i>Pig‐a</i> assay: A report from the <scp>HESI GTTC</scp><i>Pig‐a</i> Workgroup
Recommendations for conducting the rodent erythrocyte <i>Pig‐a</i> assay: A report from the <span>HESI GTTC</span><i>Pig‐a</i> Workgroup Open
The rodent Pig‐a assay is a flow cytometric, phenotype‐based method used to measure in vivo somatic cell mutation. An Organization for Economic Co‐operation and Development (OECD) test guideline is currently being developed to support rout…
View article: A review of the genotoxicity of the industrial chemical cumene
A review of the genotoxicity of the industrial chemical cumene Open
The purpose of this review is to evaluate the literature on the genotoxicity of cumene (CAS # 98-82-8) and to assess the role of mutagenicity, if any, in the mode of action for cumene-induced rodent tumors. The studies reviewed included mi…
View article: Weight of evidence analysis of the tumorigenic potential of 1,3-dichloropropene supports a threshold-based risk assessment
Weight of evidence analysis of the tumorigenic potential of 1,3-dichloropropene supports a threshold-based risk assessment Open
1,3-Dichloropropene (1,3-D; CAS #542-75-6) is a fumigant used for preplant treatment of soil to control parasitic nematodes and manage soil borne diseases for numerous fruit, vegetable, field and tree and vine crops across diverse global a…
View article: <i>In vivo</i> mutagenicity evaluation of the soil fumigant 1,3-dichloropropene
<i>In vivo</i> mutagenicity evaluation of the soil fumigant 1,3-dichloropropene Open
1,3-Dichloropropene (1,3-D; CAS No. 542-75-6) is a soil fumigant used for the control of nematodes in agriculture. There is an extensive database on the genotoxicity of 1,3-D and many of the published studies are confounded by the presence…
View article: Utility of a next generation framework for assessment of genomic damage: A case study using the industrial chemical benzene
Utility of a next generation framework for assessment of genomic damage: A case study using the industrial chemical benzene Open
We recently published a next generation framework for assessing the risk of genomic damage via exposure to chemical substances. The framework entails a systematic approach with the aim to quantify risk levels for substances that induce gen…
View article: The food contaminant acetamide is not an in vivo clastogen, aneugen, or mutagen in rodent hematopoietic tissue
The food contaminant acetamide is not an in vivo clastogen, aneugen, or mutagen in rodent hematopoietic tissue Open
Acetamide (CAS 60-35-5) is classified by IARC as a Group 2B, possible human carcinogen, based on the induction of hepatocellular carcinomas in rats following chronic exposure to high doses. Recently, acetamide was found to be present in a …
View article: Considerations for the Use of Mutation as a Regulatory Endpoint in Risk Assessment
Considerations for the Use of Mutation as a Regulatory Endpoint in Risk Assessment Open
Assessment of a chemical's potential to cause permanent changes in the genetic code has been a common practice in the industry and regulatory settings for decades. Furthermore, the genetic toxicity battery of tests has typically been emplo…